ORLANDO — A community-based lifestyle intervention program significantly reduced body weight and waist circumference and lowered fasting blood glucose levels at 1 year compared with usual care in a study of 301 adults with prediabetes.
Results of the Healthy Living Partnerships to Prevent Diabetes (HELP PD) study were presented by Dr. David C. Goff, chair of the department of epidemiology and prevention at Wake Forest University. The intervention was modeled after the landmark Diabetes Prevention Program (DPP) study, in which individuals at high risk for type 2 diabetes who received individual lifestyle counseling had a 58% reduction in the development of diabetes over 3 years (N. Engl. J. Med. 2002;346:393-403). Both studies were funded by the National Institute of Diabetes and Digestive and Kidney Diseases.
“In the 7 years since publication of the DPP, there has been great interest in developing and testing ways to translate those behavioral weight loss approaches to community settings in ways that can reach the large population of people with prediabetes,” Dr. Goff said during a press briefing at the meeting.
In HELP PD, the DPP intervention was modified to a group-based counseling session with about 10-14 people per group. In another difference, specially trained lay community health workers who had brought their diabetes under control delivered the intervention, which included encouragement to change eating behaviors and to exercise for up to 180 minutes per week, with an emphasis on walking.
In the intervention group, sessions were held weekly for the first 6 months and monthly for the next 18 months. The usual-care group received two individual sessions with a registered dietician during the first 3 months of the study and a monthly newsletter throughout the 2 years. Telephone calls were also included.
The subject population was about 40% male, about 75% white, and slightly less than 25% were African American. They had a mean age of 58 years, a mean body weight of 94 kg a mean BMI of 33 kg/m
Subjects in the intervention group lost an average of 7 kg in the first intervention year, compared with a loss of 1.5 kg in the usual-care group. Waist circumference was reduced by 5.9 cm in the intervention group, compared with less than 1 cm with usual care.
The primary end point, fasting glucose, dropped by 4.2 mg/dL in the first year, compared with 0.3 mg/dL in the usual-care group. All of these comparisons are highly statistically significant. Fasting insulin levels also declined, Dr. Goff said.
Neither overall nor serious adverse events differed between the two groups. Although the sample wasn't large enough to assess the development of diabetes with statistical significance, there have been fewer cases among the intervention group participants, consistent with the 4-mg/dL reduction in fasting glucose. Monitoring for diabetes will be continued into a second year along with the other parameters, he said.
About 3,000 diabetes education programs around the country are now recognized by the ADA. In order for this intervention to take place, staff would need to be trained to administer it and policies would need to change to allow reimbursement for treatment of prediabetes, Dr. Goff noted.
Disclosures: Dr. Goff stated that he has received funding for diabetes-related research from Merck and has served on a safety monitoring board for Takeda.